LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K063699
    Device Name
    IMDX SYSTEMS
    Manufacturer
    NOVX SYSTEMS INC.
    Date Cleared
    2007-06-01

    (170 days)

    Product Code
    DJG,DIF,DIO,DJR,DKB,DMT,JJE,JXM
    Regulation Number
    862.3650
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IMDX SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The iMDx™ System is an in vitro diagnostic device consisting of iMDx™ Analyzer and iMDxPrep™ Assays. The system is an expandable, closed system. All assays are designed for use with automated iMDx™ Analyzer. The system has been designed to be used by practitioners in drug rehabilitation clinics, physician offices, and clinical laboratories.

    The Opiates (Morphine), Benzodiazepine (Oxazepam) and Cocaine Metabolite (Benzoylecgonine) Assays are an enzyme immunoassav with a 300ng/mL cutoff. These assays are intended for use in the qualitative and semi-quantitative analysis of Opiates, Benzodiazepine and Cocaine Metabolite in human urine. The Methadone Metabolite (EDDP) Assay is an enzyme immunoassay with a 100ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analysis of Methadone Metabolite in human urine. For point of care use semi-quantitative analysis is only for estimation of dilution for confirmation testing.

    The Ethyl Alcohol Assay is an enzymatic assay intended for use in quantitative analysis of ethyl alcohol in human urine. Measurements contained are used in the diagnosis and treatment of alcohol intoxication and poisoning.

    All assays provide only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) analysis is performed. FOR USE BY TRAINED PERSONNEL ONLY. Only operators trained in the use of the iMDx™ System by NOVX personnel should perform these procedures.

    Device Description

    The iMDx™ System is an in vitro diagnostic device consisting of iMDx™ Analyzer and iMDxPrep™ Assays. The system is an expandable, closed system. All assays are designed for use with automated iMDx™ Analyzer.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to NOVX Systems Inc. regarding their iMDx™ System. It states that the device has been found substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information regarding acceptance criteria, study data, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory approval letter, not a technical report detailing performance studies.

    Therefore, I cannot provide the requested information from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1